European Journal of Obstetrics & Gynecology and Reproductive Biology 194 (2015) 228–232
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Systematic assessment of surgical complications in laparoscopically assisted vaginal hysterectomy for pelvic organ prolapse Anke R. Mothes, Marc P. Radosa, Ingo B. Runnebaum * Department of Gynaecology, Jena University Hospital, Friedrich-Schiller-University Jena, Bachstreet 18, D-07743 Jena, Germany
A R T I C L E I N F O
A B S T R A C T
Article history: Received 4 July 2015 Received in revised form 25 August 2015 Accepted 17 September 2015
Objective: To assess patient safety and complication rates in native tissue vaginal prolapse repair combined with laparoscopically assisted vaginal hysterectomy and prophylactic salpingectomy/ salpingoophorectomy. Study design: This was a single-centre retrospective study conducted at the University Hospital, Urogynaecological Unit, with a certified urogynaecological surgeon. A cohort of 321 consecutive patients received laparoscopically assisted vaginal hysterectomy for pelvic organ prolapse grade II–IV combined with defect-specific vaginal native tissue repair. Analysis of the total cohort and subgroups according to prolapse grade and concomitant laparoscopic procedures was performed. Student’s t-tests and chisquared tests were used for descriptive statistical analysis. Surgical complications were classified using the Clavien–Dindo (CD) classification system of surgical complications. Results: Complications were classified as CD I (1.87%), CD II (13.39%), CD IIIa (0.62%), and CD IIIb (1.87%); no CD IV or CD V complication occurred. One (0.31%) intraoperative bladder lesion, but no rectal lesion, ureter lesion, or intraoperative haemorrhage requiring blood transfusion, was noted. The overall morbidity rate, including the intraoperative bladder lesion and the CD I complication, was 18.06%. All (n = 321) patients underwent prophylactic salpingectomy. Additional oophorectomy was performed in 222 post-menopausal patients. Pelvic adhesions were found in 123 (38.31%) patients and 148 (46%) patients presented grade IV prolapse. Operating time was longer for grade IV than for grade II/III prolapse (p < 0.01), but CD III complication rates did not differ between these groups. Operating time was longer when laparoscopic adhesiolysis was performed (p = 0.025), but this factor did not affect CD III complication rates. Conclusions: The combination of vaginal site-specific prolapse repair with laparoscopically assisted hysterectomy leads to low complication rates. Prophylactic salpingectomy or salpingoophorectomy can be performed safely in combination with hysterectomy for pelvic organ prolapse. In terms of surgical safety laparoscopy seems to be a meaningful addition to vaginal native tissue prolapse surgery. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Pelvic organ prolapse Native tissue repair Laparoscopically assisted hysterectomy Clavien–Dindo classification Surgical safety
Introduction Patients undergoing surgery deserve as much safety as possible. For optimal therapeutic results, it is well accepted that vaginal prolapse repair requires an advanced experience level in gynaecologic surgery. In older patients with pelvic organ prolapse (POP), uterine size is often reduced, but uterine shape – namely, cervical elongation – presents a surgical challenge [1]. Extensive vaginal preparation along an elongated uterine cervix [1] can cause surgical complications affecting neighbouring organs, such as the urinary bladder, ureters, and rectum, and large wound surface area
* Corresponding author. Tel.: +49 3641 9 33063; fax: +49 3641 9 33064. E-mail address: [email protected] (I.B. Runnebaum). http://dx.doi.org/10.1016/j.ejogrb.2015.09.026 0301-2115/ß 2015 Elsevier Ireland Ltd. All rights reserved.
can lead to the development of haemorrhage and haematoma. When the vaginal approach is used, additional detailed laparoscopic visualisation of pelvic structures [2] can increase the safety of surgical preparation, thereby decreasing complication rates. Another well-known advantage of laparoscopy is that it enables the safe performance of salpingectomy or salpingoophorectomy [3,4]. For benign conditions requiring hysterectomy, several authors have advocated combination with salpingectomy or salpingoophorectomy as the standard of care [4–8]. Other authors, however, consider current evidence to be insufficiently convincing to recommend prophylactic salpingectomy in combination with every hysterectomy [9]. Several standardised classification systems for the evaluation of surgical morbidity associated with different operative techniques for POP have been proposed recently [10,11]. The objective of this
A.R. Mothes et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 194 (2015) 228–232
retrospective analysis was to assess surgical complications of laparoscopically assisted vaginal hysterectomy (LAVH) for POP using the Clavien–Dindo (CD) classification, a valid and widely adopted tool for quality assessment in urological surgery [11]. We hypothesised that in terms of safety laparoscopic assistance could be a meaningful addition to vaginal hysterectomy for POP. The results of this study can facilitate the development of strategies to improve the safety of patients undergoing prolapse surgery. Materials and methods Data from 321 consecutive patients who underwent type III LAVH [2] combined with vaginal native tissue repair for POP, performed by a certified pelvic floor surgeon between 2009 and 2014, were analysed. In all cases, the hysterectomy procedure was indicated due to uterine pathology (uterine fibroids, uterine cervical elongation) or demanded by the patient. Procedures included laparoscopic panoramic examination of the peritoneal cavity for pathologic findings, opening of the bladder fold and preparation along the elongated uterine cervix (Fig. 1), concomitant laparoscopic procedures (i.e. salpingectomy, salpingoophorectomy, adhesiolysis, myomectomy) when required, defect-specific vaginal repair, extensive vaginal preparation in cases of grade IV prolapse [12], and a laparoscopic ‘second look’ for trans-peritoneal visualisation of bilateral ureter peristalsis and haemostasis at the vaginal apex. In pre- and peri-menopausal women and on patient demand, the ovaries were preserved. Laparoscopic bladder preparation along the elongated uterine cervix reduces the extent of vaginal preparation required. It also allows the anterior opening of the peritoneal cavity in a distal location, as well as improved visualisation of tissue layers (Fig. 2) at vaginal preparation steps. The semi-circular colpotomy shown in Fig. 2 was performed vaginally but the distal site of the anterior peritoneal opening was determined by prior laparoscopic preparation steps along the uterine cervix as mentioned before.
229
Defect-specific vaginal native tissue repair consisted of lateral paravaginal or central anterior compartment repair, posterior compartment repair, and sacrospinous fixation, depending on the presenting pelvic-floor defect pattern. The ‘second look’ approach required the patients’ position on the operating table to be changed from dorsal to the lithotomy position, followed by a return to dorsal. Intraoperative suprapubic catheter insertion was not performed routinely. Standard intra- and postoperative inpatient care included the use of single-shot antibiotics (Cefuroxim 1500 mg, Hikma Pharma GmbH, Gra¨felfing, Germany and Metronidazol 500 mg, Actavis Group PTC, Hafnarfjo¨rdur, Island), vaginal packing with local haemostatic agents (Gelaspon1, Chauvin GmbH, Berlin, Germany) for 24 h, vaginal iodine (Traumasept1, Dr. Wolff, Bielefeld, Germany) and estriol (Oekolp1 0.03 mg, DR. KADE Pharma, Berlin, Germany) suppositories on alternating postoperative days, transurethral catheters for two postoperative days, and lactulose syrup (Bifiteral1 667 g/l, Abbott, Hannover, Germany) to prevent constipation. The following data were collected from the hospital’s computerised database, as well as handwritten and electronic patient charts: number of consecutive prolapse hysterectomies performed, concomitant performance of laparoscopic procedures (i.e. adhesiolysis, salpingectomy, salpingoophorectomy), number of grade IV prolapses, presence of uterine cervical elongation, uterine weight, patient’s body mass index (BMI), operating time, and perioperative complications. Cervical elongation was defined as a corpus:cervix ratio 1.5 [13]. Surgical complications were classified using the CD system. Briefly, complications were classified according to the need for postoperative medical or surgical interventions in a patient-centred approach [14]. The evaluation interval comprised the duration of hospitalisation and a 48-h re-admission period. Data were analysed using the Statistical Package for the Social Sciences (SPSS) software (version 15.0; SPSS Inc., Chicago, IL, USA). Student’s t-test and the chi-squared test were used for descriptive analysis.
Fig. 1. Laparoscopic preparation of the bladder fold. Note the unexpected finding of adhesions on the bladder fold.
A.R. Mothes et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 194 (2015) 228–232
230
Fig. 2. Vaginal preparation of the bladder fold.
This research proposal was covered by the study approval for data use and clinical studies of the General Ethics Commission, Faculty of Medicine, Jena University Hospital, Germany (No. 430001/15). Additional ethical approval was not necessary from the Ethics Commission of the Faculty of Medicine, Jena University Hospital, Germany, as anonymised data only were analysed in this study. Results Baseline characteristics of the study cohort are shown in Table 1. LAVH for POP was performed in 321 patients and combined with bilateral salpingoophorectomy in 198 patients and unilateral salpingoophorectomy in 24 patients. In 99 patients, hysterectomy was combined with bilateral salpingectomy with both ovaries left in place. Sacrospinous fixation for level I defects [15] was performed in 165 (51.40%) patients. Pelvic adhesions were found in 123 (38.31%) patients. Other intraoperative findings that could influence complication rates were duplex ureter (n = 1) and sigmoid diverticulosis combined with adhesions to the left pelvic wall (n = 26 [8.1%]). Uterine weight was available in 314 cases, and the mean value was 78.54 (SD 64.27) g. Fibroid
Table 1 Baseline characteristics of the study population (n = 321). Variable
Mean SD
Age (years) Body mass index (kg/m2) Prolapse grade II/IIIa Prolapse grade IVa
63.30 10.30 29.18 11.28 54% (173/321) 46% (148/321)
a
International Continence Society [13] nomenclature.
uterus weight > 70 g was found in 120 (37.38%) patients (mean 129.40 [SD 80.44] g; range 70–580 g). Multiple fibroids, including those located at the uterine cervical site, were found in 67 cases. In 314 (97.82%) cases, the uterine cervix was elongated [1,13]. Mean operating time was 155.17 (SD 34.47) min. Unpaired Student’s t-tests showed that operating time was longer for grade IV than for grade II/III prolapse (p < 0.01), but the CD III complication rate did not differ between these groups (chisquared test, p = 0.66). Operating time was longer when laparoscopic adhesiolysis was performed (Student’s t-test, p = 0.025), but the CD III complication rate did not differ according to this variable (chi-squared test, p = 0.51). In 34 patients with slight disseminated bleeding from the peritoneal preparation line, local haemostatic agents (Tabotamp1, Ethicon, Neuchatel, Switzerland) were successfully applied intraoperatively via the laparoscopic approach to avoid cauterisation near the ureters. All operations were completed successfully. One (0.31%) intraoperative bladder lesion, but no rectal lesion, ureter lesion, or intraoperative haemorrhage requiring blood transfusion, was noted. Complications were classified as CD I (1.87% of patients), CD II (13.39%), CD IIIa (0.62%), and CD IIIb (1.87%); no CD IV or CD V complication occurred (Table 2). Postoperative urinary tract infections requiring antibiotics (CD II) developed in 25 (7.78%) patients, post-void residual volume 100 ml (CD II) was detected by ultrasound within 5 postoperative days and treated with oral distigmine in 18 (5.61%) patients, and suprapubic catheter insertion (CD IIIa) was required for two (0.62%) patients. Asymptomatic superficial gluteal haematoma < 3 cm after sacrospinous fixation was noted in six (1.87%) patients and classified as a CD I complication because no medical or surgical intervention was necessary. No wound infection or vault haematoma was found. Six patients underwent
A.R. Mothes et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 194 (2015) 228–232 Table 2 Clavien–Dindo classification of postoperative surgical complications in the study cohort (n = 321). Clavien–Dindo gradea
n (%)
I
6 (1.87)
II
43 (13.39)
IIIa
2 (0.62)
IIIb
6 (1.87)
Complication Superficial, asymptomatic gluteal haematoma
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Systematic assessment of surgical complications in laparoscopically assisted vaginal hysterectomy for pelvic organ prolapse Anke R. Mothes, Marc P. Radosa, Ingo B. Runnebaum * Department of Gynaecology, Jena University Hospital, Friedrich-Schiller-University Jena, Bachstreet 18, D-07743 Jena, Germany
A R T I C L E I N F O
A B S T R A C T
Article history: Received 4 July 2015 Received in revised form 25 August 2015 Accepted 17 September 2015
Objective: To assess patient safety and complication rates in native tissue vaginal prolapse repair combined with laparoscopically assisted vaginal hysterectomy and prophylactic salpingectomy/ salpingoophorectomy. Study design: This was a single-centre retrospective study conducted at the University Hospital, Urogynaecological Unit, with a certified urogynaecological surgeon. A cohort of 321 consecutive patients received laparoscopically assisted vaginal hysterectomy for pelvic organ prolapse grade II–IV combined with defect-specific vaginal native tissue repair. Analysis of the total cohort and subgroups according to prolapse grade and concomitant laparoscopic procedures was performed. Student’s t-tests and chisquared tests were used for descriptive statistical analysis. Surgical complications were classified using the Clavien–Dindo (CD) classification system of surgical complications. Results: Complications were classified as CD I (1.87%), CD II (13.39%), CD IIIa (0.62%), and CD IIIb (1.87%); no CD IV or CD V complication occurred. One (0.31%) intraoperative bladder lesion, but no rectal lesion, ureter lesion, or intraoperative haemorrhage requiring blood transfusion, was noted. The overall morbidity rate, including the intraoperative bladder lesion and the CD I complication, was 18.06%. All (n = 321) patients underwent prophylactic salpingectomy. Additional oophorectomy was performed in 222 post-menopausal patients. Pelvic adhesions were found in 123 (38.31%) patients and 148 (46%) patients presented grade IV prolapse. Operating time was longer for grade IV than for grade II/III prolapse (p < 0.01), but CD III complication rates did not differ between these groups. Operating time was longer when laparoscopic adhesiolysis was performed (p = 0.025), but this factor did not affect CD III complication rates. Conclusions: The combination of vaginal site-specific prolapse repair with laparoscopically assisted hysterectomy leads to low complication rates. Prophylactic salpingectomy or salpingoophorectomy can be performed safely in combination with hysterectomy for pelvic organ prolapse. In terms of surgical safety laparoscopy seems to be a meaningful addition to vaginal native tissue prolapse surgery. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Pelvic organ prolapse Native tissue repair Laparoscopically assisted hysterectomy Clavien–Dindo classification Surgical safety
Introduction Patients undergoing surgery deserve as much safety as possible. For optimal therapeutic results, it is well accepted that vaginal prolapse repair requires an advanced experience level in gynaecologic surgery. In older patients with pelvic organ prolapse (POP), uterine size is often reduced, but uterine shape – namely, cervical elongation – presents a surgical challenge [1]. Extensive vaginal preparation along an elongated uterine cervix [1] can cause surgical complications affecting neighbouring organs, such as the urinary bladder, ureters, and rectum, and large wound surface area
* Corresponding author. Tel.: +49 3641 9 33063; fax: +49 3641 9 33064. E-mail address: [email protected] (I.B. Runnebaum). http://dx.doi.org/10.1016/j.ejogrb.2015.09.026 0301-2115/ß 2015 Elsevier Ireland Ltd. All rights reserved.
can lead to the development of haemorrhage and haematoma. When the vaginal approach is used, additional detailed laparoscopic visualisation of pelvic structures [2] can increase the safety of surgical preparation, thereby decreasing complication rates. Another well-known advantage of laparoscopy is that it enables the safe performance of salpingectomy or salpingoophorectomy [3,4]. For benign conditions requiring hysterectomy, several authors have advocated combination with salpingectomy or salpingoophorectomy as the standard of care [4–8]. Other authors, however, consider current evidence to be insufficiently convincing to recommend prophylactic salpingectomy in combination with every hysterectomy [9]. Several standardised classification systems for the evaluation of surgical morbidity associated with different operative techniques for POP have been proposed recently [10,11]. The objective of this
A.R. Mothes et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 194 (2015) 228–232
retrospective analysis was to assess surgical complications of laparoscopically assisted vaginal hysterectomy (LAVH) for POP using the Clavien–Dindo (CD) classification, a valid and widely adopted tool for quality assessment in urological surgery [11]. We hypothesised that in terms of safety laparoscopic assistance could be a meaningful addition to vaginal hysterectomy for POP. The results of this study can facilitate the development of strategies to improve the safety of patients undergoing prolapse surgery. Materials and methods Data from 321 consecutive patients who underwent type III LAVH [2] combined with vaginal native tissue repair for POP, performed by a certified pelvic floor surgeon between 2009 and 2014, were analysed. In all cases, the hysterectomy procedure was indicated due to uterine pathology (uterine fibroids, uterine cervical elongation) or demanded by the patient. Procedures included laparoscopic panoramic examination of the peritoneal cavity for pathologic findings, opening of the bladder fold and preparation along the elongated uterine cervix (Fig. 1), concomitant laparoscopic procedures (i.e. salpingectomy, salpingoophorectomy, adhesiolysis, myomectomy) when required, defect-specific vaginal repair, extensive vaginal preparation in cases of grade IV prolapse [12], and a laparoscopic ‘second look’ for trans-peritoneal visualisation of bilateral ureter peristalsis and haemostasis at the vaginal apex. In pre- and peri-menopausal women and on patient demand, the ovaries were preserved. Laparoscopic bladder preparation along the elongated uterine cervix reduces the extent of vaginal preparation required. It also allows the anterior opening of the peritoneal cavity in a distal location, as well as improved visualisation of tissue layers (Fig. 2) at vaginal preparation steps. The semi-circular colpotomy shown in Fig. 2 was performed vaginally but the distal site of the anterior peritoneal opening was determined by prior laparoscopic preparation steps along the uterine cervix as mentioned before.
229
Defect-specific vaginal native tissue repair consisted of lateral paravaginal or central anterior compartment repair, posterior compartment repair, and sacrospinous fixation, depending on the presenting pelvic-floor defect pattern. The ‘second look’ approach required the patients’ position on the operating table to be changed from dorsal to the lithotomy position, followed by a return to dorsal. Intraoperative suprapubic catheter insertion was not performed routinely. Standard intra- and postoperative inpatient care included the use of single-shot antibiotics (Cefuroxim 1500 mg, Hikma Pharma GmbH, Gra¨felfing, Germany and Metronidazol 500 mg, Actavis Group PTC, Hafnarfjo¨rdur, Island), vaginal packing with local haemostatic agents (Gelaspon1, Chauvin GmbH, Berlin, Germany) for 24 h, vaginal iodine (Traumasept1, Dr. Wolff, Bielefeld, Germany) and estriol (Oekolp1 0.03 mg, DR. KADE Pharma, Berlin, Germany) suppositories on alternating postoperative days, transurethral catheters for two postoperative days, and lactulose syrup (Bifiteral1 667 g/l, Abbott, Hannover, Germany) to prevent constipation. The following data were collected from the hospital’s computerised database, as well as handwritten and electronic patient charts: number of consecutive prolapse hysterectomies performed, concomitant performance of laparoscopic procedures (i.e. adhesiolysis, salpingectomy, salpingoophorectomy), number of grade IV prolapses, presence of uterine cervical elongation, uterine weight, patient’s body mass index (BMI), operating time, and perioperative complications. Cervical elongation was defined as a corpus:cervix ratio 1.5 [13]. Surgical complications were classified using the CD system. Briefly, complications were classified according to the need for postoperative medical or surgical interventions in a patient-centred approach [14]. The evaluation interval comprised the duration of hospitalisation and a 48-h re-admission period. Data were analysed using the Statistical Package for the Social Sciences (SPSS) software (version 15.0; SPSS Inc., Chicago, IL, USA). Student’s t-test and the chi-squared test were used for descriptive analysis.
Fig. 1. Laparoscopic preparation of the bladder fold. Note the unexpected finding of adhesions on the bladder fold.
A.R. Mothes et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 194 (2015) 228–232
230
Fig. 2. Vaginal preparation of the bladder fold.
This research proposal was covered by the study approval for data use and clinical studies of the General Ethics Commission, Faculty of Medicine, Jena University Hospital, Germany (No. 430001/15). Additional ethical approval was not necessary from the Ethics Commission of the Faculty of Medicine, Jena University Hospital, Germany, as anonymised data only were analysed in this study. Results Baseline characteristics of the study cohort are shown in Table 1. LAVH for POP was performed in 321 patients and combined with bilateral salpingoophorectomy in 198 patients and unilateral salpingoophorectomy in 24 patients. In 99 patients, hysterectomy was combined with bilateral salpingectomy with both ovaries left in place. Sacrospinous fixation for level I defects [15] was performed in 165 (51.40%) patients. Pelvic adhesions were found in 123 (38.31%) patients. Other intraoperative findings that could influence complication rates were duplex ureter (n = 1) and sigmoid diverticulosis combined with adhesions to the left pelvic wall (n = 26 [8.1%]). Uterine weight was available in 314 cases, and the mean value was 78.54 (SD 64.27) g. Fibroid
Table 1 Baseline characteristics of the study population (n = 321). Variable
Mean SD
Age (years) Body mass index (kg/m2) Prolapse grade II/IIIa Prolapse grade IVa
63.30 10.30 29.18 11.28 54% (173/321) 46% (148/321)
a
International Continence Society [13] nomenclature.
uterus weight > 70 g was found in 120 (37.38%) patients (mean 129.40 [SD 80.44] g; range 70–580 g). Multiple fibroids, including those located at the uterine cervical site, were found in 67 cases. In 314 (97.82%) cases, the uterine cervix was elongated [1,13]. Mean operating time was 155.17 (SD 34.47) min. Unpaired Student’s t-tests showed that operating time was longer for grade IV than for grade II/III prolapse (p < 0.01), but the CD III complication rate did not differ between these groups (chisquared test, p = 0.66). Operating time was longer when laparoscopic adhesiolysis was performed (Student’s t-test, p = 0.025), but the CD III complication rate did not differ according to this variable (chi-squared test, p = 0.51). In 34 patients with slight disseminated bleeding from the peritoneal preparation line, local haemostatic agents (Tabotamp1, Ethicon, Neuchatel, Switzerland) were successfully applied intraoperatively via the laparoscopic approach to avoid cauterisation near the ureters. All operations were completed successfully. One (0.31%) intraoperative bladder lesion, but no rectal lesion, ureter lesion, or intraoperative haemorrhage requiring blood transfusion, was noted. Complications were classified as CD I (1.87% of patients), CD II (13.39%), CD IIIa (0.62%), and CD IIIb (1.87%); no CD IV or CD V complication occurred (Table 2). Postoperative urinary tract infections requiring antibiotics (CD II) developed in 25 (7.78%) patients, post-void residual volume 100 ml (CD II) was detected by ultrasound within 5 postoperative days and treated with oral distigmine in 18 (5.61%) patients, and suprapubic catheter insertion (CD IIIa) was required for two (0.62%) patients. Asymptomatic superficial gluteal haematoma < 3 cm after sacrospinous fixation was noted in six (1.87%) patients and classified as a CD I complication because no medical or surgical intervention was necessary. No wound infection or vault haematoma was found. Six patients underwent
A.R. Mothes et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 194 (2015) 228–232 Table 2 Clavien–Dindo classification of postoperative surgical complications in the study cohort (n = 321). Clavien–Dindo gradea
n (%)
I
6 (1.87)
II
43 (13.39)
IIIa
2 (0.62)
IIIb
6 (1.87)
Complication Superficial, asymptomatic gluteal haematoma
